High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients Trial (HDVDS-HIVT)

High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients: A Double-Blind Randomized Control Trial

High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Antiretroviral therapy may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection; Hypovitaminosis D
• Intervention / Treatment: Other: placebo Oil; Drug: 25-Hydroxyvitamin D

Detailed Description

The study is designed to evaluate the effect of high dose Vitamin-D supplementation in the treatment of HIV patients with Antiretroviral therapy.

Furthermore, in secondary outcomes study will evaluate the effects of high dose vitamin-D supplementation by Pre & Post assessments of CD4 count and PCR count.

Secondary outcomes also includes the effects of high dose vitamin-D supplementation by Pre & Post assessments of SGPT, SGOT, ALP and Bilirubin.

Tertiary outcomes includes the effects of high dose vitamin-D supplementation by Pre & Post assessments of Hb, Lymphocytes, Monocytes, Eosinophil, Platelet count and Basophil count.

A sample size of 95 patients were recruited in Said Mitha Teaching Hospital Lahore.

Study is planned in two groups including 1) ARV + Vitamin-D3 2) ARV + Placebo. Methods/design: A randomized placebo controlled double-blind clinical trial of patients with age 19-50 years.

The primary outcome will be assessed by analyzing the difference change in the Vitamin-D Levels from Day 1 to Week 12. Secondary outcomes including viral load count, CD4 count, elevated levels of LFTs, will also be assessed by analyzing the mean difference in their values on week 12 after the supplementation of high dose Vitamin-D. Tertiary outcomes (Hematology) including Hb, HCT, TLC, Eosinophil's count, Neutrophils count, Monocytes and Platelets Data will be collected on a predefined Performa. All information will be entered in SPSS for the analysis.

Discussion: High dose Vitamin D supplementation in HIV-infected patients has not been previously investigated in Pakistan and it is unknown whether increasing levels is associated with improved clinical outcome or not. Therefore, it is significant to conduct a study to know the effect of vitamin D in the treatment of HIV patients with antiretroviral therapy.

Keywords: AIDS, HIV, anti-retroviral therapy, high dose 25-hydroxy Vitamin-D level, CD4 count, viral load.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab/ lahore/Pakistan
    • Lahore, Punjab/ lahore/Pakistan, Pakistan, 5200
      • Govt Said Mitha Teaching Hospital Lahore
    • Lahore, Punjab/ lahore/Pakistan, Pakistan, LAHORE
      • Fatima Majeed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age from 19 years and above
2. Vitamin-D levels less than 20ng/ml
3. Not taking any kind of Vitamin-D supplementation or Mega Doses for last six months
4. Written Informed Consent Form
5. PCR Positive Patients

Exclusion Criteria:

1. Pregnant and Lactating Women
2. Ability to take Study Medication Orally

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm: Olive oil; In control arm participants will receive Placebo (Olive Oil) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list.	Other: placebo Oil; participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4; Other Names: Olive oil
Active Comparator: Vitamin-D; In the Vitamin-D arm, participants will receive Vitamin-D (100000 IU) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list.	Drug: 25-Hydroxyvitamin D; Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4; Other Names: viatamin-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients	Optimal level of Vitamin-D3 i.e >20ng/ml in HIV patients	Within 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome is to assess the mean differences in CD4 count	Optimal value of CD4 count is 500-1500 cells/mm3 the unit of CD4 count is cells/mm3	Within 12 Weeks
To measure the effect of our intervention on PCR value copies/µL.	PCR normal value is usually comes under detected and non-detected category and its unit is copies/µL	within 12 weeks
To measure the effect of intervention on the viral load value	The normal value of viral load must be zero and measures in copies/µL of the blood.	within 12 weeks
To measure the effect of intervention on SGPT	The normal value of SGPT is measured in (µL)	Within 12 weeks
To measure the effect of intervention on SGOT	The normal value of SGOT is measured in (µL)	Within 12 weeks
To measure the effect of intervention on ALP	The normal value of ALP is measured in (µ/l)	Within 12 weeks
To measure the effect of intervention on Bilirubin	The normal value of Bilirubin measured in (mg/dl)	Within 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To access the effect of the intervention on Lymphocytes	The units for Lymphocytes is in percentage %	within 12 weeks
To access the effect of intervention on Monocytes	The units for Monocytes is in percentage %	within 12 weeks
To access the effect of intervention on Hemoglobin	The hemoglobin level is measured in g/dl	within 12 weeks
To access the effect of the intervention on Platelets count	The platelets count is normally measured in 1000/µL	Within 12 weeks.
To access the effect of the intervention on Eosionophil	The platelets count is normally measured in percentage %	Within 12 weeks
To access the effect of the intervention on Basophil	The Basophil count is normally measured in percentage %	Within 12 weeks

Collaborators and Investigators

• Sponsor: University of the Punjab
• Collaborators: The National HIV/AIDS Programme

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Nutrition Disorders; Musculoskeletal Diseases; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Immunologic Deficiency Syndromes; Rickets; Avitaminosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcifediol; Hydroxycholecalciferols
• Other Study ID Numbers: 12121218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No